The impact of metformin and physical exercise interaction on HbA1c, lipid profile and functional capacity (Metformin and physical exercise interaction)

Study identification

• EU PAS number:
  EUPAS13582
• Study ID:
  28824
• Official title and acronym:
  The impact of metformin and physical exercise interaction on HbA1c, lipid profile and functional capacity (Metformin and physical exercise interaction)
• DARWIN EU® study:
  No
• Study countries:
  Canada
• Study description:
  We aim to study the interaction between metformin use and physical exercise among diabetic patients, and examine the association between different doses of exercise on glycated haemoglobin (HbA1c) level, lipid profile and functional capacity. We will construct a cohort of diabetic and non-diabetic patients using the electronic records of the Cardiac Wellness Program in Moncton, New Brunswick. A retrospective cohort design will be used. Diabetic patients will be identified as having a recorded diagnosis of diabetes at admission. The primary outcomes will be the HbA1c level, the lipid profile and the peak functional capacity measured at discharge. Metformin use will be measured through recorded prescriptions and physical exercise will be defined as the total energy cost of exercise sessions conducted within the program period. Directed acyclic graphs (DAG) will be used to identify potential confounders. The classes of confounding variables that will be assessed include: 1) sociodemographic variables, 2) baseline comorbidities and 3) diabetes and exercise related variables. Multiple linear and logistic regression models will be used to estimate the effect of metformin use, exercise dosage, and their interaction.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Centre de formation médicale du Nouveau-Brunswick

Study timelines

Date when funding contract was signed

Planned:01/05/2016

Actual:01/05/2016

Study start date

Planned:20/06/2016

Actual:08/07/2016

Data analysis start date

Planned:31/03/2017

Date of interim report, if expected

Planned:31/07/2017

Date of final study report

Planned:31/12/2018

Sources of funding

Other

More details on funding

Maritime SPOR SUPPORT Unit (MSSU)

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable